Scientific Opinion on an application (EFSA-GMO-NL-2009-70) for the placing on the market of genetically modified drought tolerant maize MON 87460 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto

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Article
Panel on Genetically Modified Organisms
EFSA Journal
EFSA Journal 2012;10(11):2936 [42 pp.].
doi
10.2903/j.efsa.2012.2936
Panel members at the time of adoption
Salvatore Arpaia, Andrew Nicholas Edmund Birch, Andrew Chesson, Patrick du Jardin, Achim Gathmann, Jürgen Gropp, Lieve Herman, Hilde-Gunn Hoen-Sorteberg, Huw Jones, József Kiss, Gijs Kleter, Pagona Lagiou, Martinus Lovik, Antoine Messéan, Hanspeter Naegeli, Kaare Magne Nielsen, Jaroslava Ovesna, Joe Perry, Nils Rostoks and Christoph Tebbe
Acknowledgements

The Panel wishes to thank the members of the Working Groups on Molecular Characterisation, Food/Feed and Environment on GMO applications for the preparation of this Scientific Opinion; and Harry Kuiper, Fabien Nogué, Jeremy Sweet and EFSA staff members Yann Devos, Christina Ehlert, Yi Liu, Nancy Podevin and Ellen van Haver for the support provided in the preparation of this EFSA scientific output

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of the Netherlands for an application (EFSA-GMO-NL-2009-70) submitted by Monsanto
Question Number
EFSA-Q-2009-00661
Adopted
18. Oktober 2012
Published in the EFSA Journal
15. November 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Abstract

Maize MON 87460 was developed through Agrobacterium-mediated transformation and expresses the cold shock protein B (CspB) from Bacillus subtilis and neomycin phosphotransferase II (NPTII) from Escherichia coli to reduce yield loss under water-limited conditions. Maize MON 87460 contains a single copy of the cspB and nptII expression cassettes. Bioinformatic analysis of the flanking sequences and the open reading frames spanning the junctions created by the transformation did not raise safety issues. Comparative analyses established that, besides the expression of the CspB and NPTII proteins, some differences were observed in the composition of forage and grain produced from maize MON 87460 compared with its conventional counterpart, when grown under well-watered conditions. Given the magnitude of these changes and the characteristics of these endpoints, the EFSA GMO Panel concluded that the observed differences do not raise safety concerns for humans and animals. Under stressful conditions, maize MON 87460 can show enhanced agronomic performance characteristics and some differences in chemical composition in comparison with its conventional counterpart. Given the intended trait, the observed differences were not unexpected, and did indicate no safety concerns. The safety assessment identified no concerns regarding the potential toxicity and allergenicity of the CspB and NPTII proteins, or of maize MON 87460. Maize MON 87460 is as nutritious as any other maize and can be used in the same way. In cases of spillage, there are no indications of increased likelihood of the establishment or survival of feral maize plants MON 87460. Risks associated with a theoretically possible horizontal gene transfer from maize MON 87460 to bacteria have been analysed in detail, including different scenarios of integration, and did not raise safety concerns for the intended uses of maize MON 87460. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of maize MON 87460.

Keywords
GMO, maize (Zea mays), MON87460, MON 87460, drought tolerance, risk assessment, food and feed safety, environmental safety, food and feed uses, import, processing, Regulation (EC) No 1829/2003
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Number of Pages
42